1. Field of the Invention
This invention relates to a composition for treating AIDS and related conditions, and more particular, to a composition comprising at least one extract of a selected plant.
2. Description of the Prior Art
Patients with illnesses that, in retrospect, were manifestations of acquired immunodeficiency syndrome (AIDS) were first described in the summer of 1981 [CDC—Pneumocystis pneumonia—Los Angeles. MMWR 1981, 30:250-2; CDC—Kaposi's sarcoma and Pneumocystis pneumonia among homosexual men—New York City and California. MMWR 1981, 30:305-8]. A case definition of AIDS for national reporting was first published in the MMWR in September 1982 [CDC—Hepatitis B virus vaccine safety: report of an inter-agency group MMWR 1982, 31:465-67; CDC—Update on acquired immune deficiency syndrome (AIDS)—United States. MMWR 1982, 31:507-14]. Since then the definition has undergone minor revisions in the list of diseases used as indicators of underlying cellular immunodeficiency [Jaffe H W, Bregman D J, Selik R M. Acquired immune deficiency syndrome in the United States: the first 1,000 cases. J Infect Dis 1983, 148:339-45; Jaffe H W Selik R M. Acquired immune deficiency syndrome: is disseminated aspergillosis predictive of underlying cellular immune deficiency?, (Reply to letter), J Infect Dis 1984, 149:829; Selik R M, Haverkos H W, Curran J W. Acquired immune deficiency syndrome (AIDS) trends in the United States, 1978-1982. Am J Med 1984, 76:493-500; CDC, Update: acquired immunodeficiency syndrome (AIDS)—United States. MMWR 1984, 32:688-91]
Since the 1982 definition was published, human T-cell lymphotropic virus type III/lymphadenopathy-associated virus (HTLV-III/LAV) has been recognized as the cause of AIDS. The clinical manifestations of (HTLV-III/LAV) infection may be directly attributable to infection with this virus or the result of secondary conditions occurring as a consequence of immune dysfunction caused by the underlying infection with (HTLV-III/LAV). The range of manifestations may include none, nonspecific signs and symptoms of illness, autoimmune and neurologic disorders, a variety of opportunistic infections, and several types of malignancy. AIDS was defined for national reporting before its etiology was known and has encompassed only certain secondary conditions that reliably reflected the presence of a sever immune dysfunction. Current laboratory tests to detect (HTLV-III/LAV) antibody make it possible to include additional serious conditions in the syndrome, as well as to further improve the specificity of the definition used for reporting cases.
The current case definition of AIDS has provided useful data on disease trends, because it is precise, consistently interpreted, and highly specific. Other manifestations of HTLV-II/LAV infections than those currently proposed to be reported are less specific and less likely to be consistently reported nationally. Milder disease associated with HTLV-III/LAV infections and asymptomatic infections may be reportable in some states and cities but will not be nationally reportable. Because persons with less specific or milder manifestations of HTLV-III/LAV infection may be important in transmitting the virus, estimates of the number of such persons are of value. These estimates can be obtained through epidemiologic studies or special surveys in specific populations.
Issues related to the case definition of AIDS were discussed by the Conference of State and Territorial Epidemiologists (CSTE) at its annual meeting in Madison, Wis., Jun. 2-5, 1985. The CSTE approved the following resolutions:
1. that the case definition of AIDS used for national reporting continue to include only the more severe manifestations of HTLV-III/LAV infection; and
2. that the Center For Disease Control (CDC) develop more inclusive definitions and classifications of HTLV-III/LAV infection for diagnosis, treatment, and prevention, as well as for epidemiologic studies and special surveys; and
3. that the following refinements be adopted in the case definition of AIDS used for national reporting:                a. In the absence of the opportunistic diseases required by the current case definition, any of the following diseases will be considered indicative of AIDS if the patient has a positive serologic or virologic test for HTLV-III/LAV:        
1. disseminated histoplasmosis (not confined to lungs or lymph nodes), diagnosed by culture, histology, or antigen detection;
2. isosporiasis, causing chronic diarrhea (over 1 month), diagnosed by histology or stool microscopy;
3. bronchial or pulmonary candidiasis, diagnosed by microscopy or by presence of characteristic white plaques grossly on the bronchial mucosa (not by culture alone);
4. non-Hodgkins' lymphoma of high-grade pathologic type (diffuse, undifferentiated) and of B-cell unknown immunologic phenotype, diagnosed by biopsy;
5. histologically confirmed Kaposi's sarcoma in patients who are 60 years old or older when diagnosed.                b. In the absence of the opportunistic diseases required by the current case definition, a histologically confirmed diagnosis of chronic lymphoid interstitial pneumonitis in a child (under 13 years of age) will be considered indicative of AIDS unless test(s) for HTLV-III/LAV are negative.        c. Patients who have a lymphoreticular malignancy diagnosed more than 3 months after the diagnosis of an opportunistic disease used as a marker for AIDS will no longer be excluded as AIDS cases.        d. To increase the specificity of the case definition, patients will be excluded as AIDS cases if they have a negative result on testing for serum antibody to HTLV-III/LAV, have no other type of HTLV-III/LAV test with a positive result, and do not have a low number of T-helper lymphocytes or a low ratio of T-helper to T-suppressor lymphocytes. In the absence of test results, patients satisfying all other criteria in the definition will continue to be included. CDC will immediately adopt the above amendments to the case definition of AIDS for national reporting.        
This revision in the case definition will result in the reclassification of less than 1% of cases previously reported to CDC. The number of additional new cases reportable as a result of the revision is expected to be small. Cases included under the revised definition will be distinguishable from cases included under the old definition so as to provide a consistent basis for interpretation of trends. CDC will also develop draft classifications for disease manifestations of HTLV-III/LAV infections other than AIDS, distribute these widely for comment, and publish the results. Reported by Conference of State and Territorial Epidemiologists; AIDS Br., Div of Viral Diseases, Center for Infectious Disease, CDC.
Han et al. Disclosed a process for preparing an extracted substance from a mixture of a non-fat starch from Ricini Semen and a root of Coptis sp for therapeutic applications of AIDS [U.S. Pat. No. 5,928,645]. The authors maintain that the extracted substance was effective in treating AIDS but provided no clinical data as to the effect of this substance in AIDS patients. In continuing work, Han et al., demonstrated significant anti-oxidant capacity of their Ricini Semen extract using a chemiluminescence assay [Hong, E. K., Kim, Y. K. Lee, W. C., Shin, H. K., and Kim, J. B.; Measurement of antioxidation activity based on chemiluminescence reaction. In Bioluminescence and Chemiluminescence (Status Report), Eds. Szalay, A. A., Kricka, L. J., and Stanley, P., John Wiley & Sons Ltd. London, England, pp. 244-246, 1993]. Antioxidant activity of Ricini Semen extract was compared with t-butylhydroxy toluene (BHT), a potent antioxidant known to people of ordinary skill in the field of the invention. The authors therefore proposed that Ricini Semen extract has anti-HIV effect although no clinical data was presented. Investigations of the Ricini Semen extract in laboratory animals by sub-cutaneous injection revealed significant tubular necrosis, glomerulonephritis, and vacuolation in livers of male and female mice, interstitial nephritis being demonstrated as well in female mice. Rats showed similar symptoms in both of the male and female. Mitosis in the liver was typically found, and extramedullary hematopoiesis in the liver and spleen also were frequently observed. Other organs were not changed compared to controls [U.S. Pat. No. 5,928,645].
Chen et al., [U.S. Pat. No. 6,077,512] disclosed a novel topical treatment method for curing black foot disease using plant extracts. The extract medicament comprised a basis part consisting of equal amounts of ground, powdered, and mixed clove, frankincense, myrrha, fhizama arisaematis, pinellia, monkshood (root) or kusnezoff monkshood (root), and tuber of bamboo-leaved orchid, and an adjuvant part consisting of equal amounts of round, powdered, and mixed borneol, powdered soy bean, borax, coptis root and/or phellodendron amureause, and sepia aculeata. The medicine is used in such a manner that the powdered basis part is mixed and stirred with tea water until it becomes plaster-like, and the adjuvant part is scattered in dry form onto the wound or swollen area caused by the black foot disease before the plaster-like basis part is applied to the wound or swollen area about 0.5 cm in thickness. The wound is then bandaged and the medicine is renewed once or twice a day until fresh flesh appears in the wound. Thereafter, the medicine is continuously applied but in a dry form until the wound is completely healed. The extract medicament composition taught by Chen et al., does not have any impact on AIDS itself as a systemic disease.